Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT04201015

Optimising Pacing for Contractility 2

Led by University of Leeds · Updated on 2024-09-26

400

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over and a small parallel group feasibility study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled 3-arm parallel group trial whether optimal programming versus standard rate-response programming versus no rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity and what the mechanisms of this might be. 450 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test, complete quality of life questionnaires and be offered the opportunity to participate in a series of mechanistic substudies. They will then be randomised to optimal rate-response settings, standard rate response settings or no rate-response settings and followed up at 6 months at which point the tests will be repeated.

CONDITIONS

Official Title

Optimising Pacing for Contractility 2

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical, echocardiographic and neurohormonal evidence of heart failure
  • Cardiac pacemaker
  • Able to perform a peak exercise test
  • Willing and able to give informed consent
Not Eligible

You will not qualify if you...

  • Angina pectoris symptoms limiting exercise tolerance
  • Unstable heart failure symptoms, including medical therapy changes in the last three months
  • Poor image quality on echocardiogram
  • Use of calcium channel blockers (CCBs)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Leeds General Infirmary

Leeds, United Kingdom

Actively Recruiting

Loading map...

Research Team

K

Klaus K Witte, MD

CONTACT

K

Klaus Witte

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here